Director of Regulatory Strategy

Job Summary

Seeking a highly experienced Director of Regulatory Strategy, the full-time salaried position will provide strategic leadership for regulatory submissions and development plans related to oncology, working remotely to ensure compliance and alignment with company objectives.

Key responsibilities

• Lead the development and execution of regulatory strategies for clinical programs, ensuring alignment with international regulations
• Oversee the preparation and submission of regulatory documents, including INDs and BLAs, while maintaining high-quality standards
• Collaborate with cross-functional teams and global health authorities to drive regulatory initiatives and support clinical development strategies

Required qualifications

• Minimum of twelve (12) years of regulatory affairs experience in the pharmaceutical or biotechnology industry, with a focus on oncology
• Master's degree in life sciences, pharmacy, or a related field; PhD preferred
• Proven track record of leading successful regulatory submissions and achieving market approvals
• Extensive experience with BLA/MAA submissions and knowledge of international regulations
• Strong leadership skills and ability to manage cross-functional teams effectively